NCT03234972CompletedPhase 3
A Study to Compare Daratumumab, Bortezomib, and Dexamethasone (DVd) vs Bortezomib and Dexamethasone (Vd) in Chinese Participants With Relapsed or Refractory Multiple Myeloma
A Randomized, Multicenter, Open-label, Phase 3 Study to Compare Daratumumab, Bortezomib, and Dexamethasone (DVd) vs Bortezomib and Dexamethasone (Vd) in Chinese Subjects With Relapsed or Refractory Multiple Myeloma
Source: ClinicalTrials.gov · Last updated 29 May 2024
Brief summary (registry, in English)
The primary purpose of this study is to compare the efficacy of daratumumab when combined with Velcade (bortezomib) and dexamethasone (DVd) to that of Velcade and dexamethasone (Vd), in terms of progression free survival (PFS) in Chinese participants with relapsed or refractory multiple myeloma (MM).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 213 (actual)
- First submitted
- 27 Jul 2017
- Start date
- 30 Nov 2017
- Primary completion date
- 7 Oct 2019
- Lead sponsor
- Janssen Research & Development, LLC
- Diseases
- Multiple myeloma
- NCT number
- NCT03234972
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 213
- From 30 Nov 2017 to the primary completion date, 7 Oct 2019
- 27 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received daratumumab or other anti-CD38 therapies
- Refractory to Velcade, or another proteasome inhibitor (PI), like ixazomib and carfilzomib (ie, participant had progression of disease while receiving Velcade therapy or within 60 days of ending Velcade therapy, or another PI, like ixazomib and carfilzomib, etc)
- Planning to undergo a stem cell transplant prior to progression of disease on this study, that is ie, these participants should not be enrolled in order to reduce disease burden prior to transplant
Other illness
- History of malignancy (other than MM) within 3 years before the date of randomization
Other
- Intolerant to Velcade (that is \[ie\], discontinued due to any adverse event while on Velcade treatment)
Who the study is looking for
- Documented multiple myeloma (MM) as defined by the criteria: monoclonal plasma cells in the bone marrow greater than or equal to (\>=) 10 percent (%) at some point in the participant's disease course or presence of a biopsy-proven plasmacytoma
- Received at least 1 prior line of therapy for MM
- Documented evidence of progressive disease (PD) based on investigator's determination of response as defined by the International Myeloma Working Group (IMWG) criteria on or after their last regimen
- Achieved a response (partial response \[PR\] or better based on investigator's determination of response by the IMWG criteria) to at least 1 prior regimen
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (27)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| West China Hospital Si Chuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Xinqiao Hospital of the Third Military Medical University Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Fujian Meidical University Union Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Nanfang Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The First Affiliated Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Guangdong Provincial People's Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| First Affiliated Hospital Medical School of Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| First Affiliated Hospital of Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Jiangsu Province Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Nanjing Drum Tower hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Zhongda Hospital Southeast University Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Shanghai Changzheng Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Ruijin Hospital Shanghai Jiao Tong University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| First Affiliated Hospital SooChow University Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| Tianjin Cancer Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Institute of Hematology and Blood Diseases Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Tianjin Medical University General Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Tongji Hospital Tongji Medical College of Hust Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Tangdu Hospital Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Tri-Service General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.